Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy

Dilated Cardiomyopathy Clinical Trial

— STEMDILCARD  

Official title:

Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615394
• Other study ID #: UP3549/04
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 1, 2008
• Last updated: February 1, 2008
• Start date: April 2004
• Est. completion date: December 2006

Study information

• Verified date: February 2008
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brasil:CONEP, National Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• diagnosis made at more than two years and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy

• left ventricular ejection fraction (LVEF) less than 35%, by echocardiogram

• age below 60 years

• absence of neoplasm

• absence of hematologic disease or systemic disease

• no previous cardiac intervention

Exclusion Criteria:

• episodes of tachycardia or ventricular fibrillation

• severe or moderated mitral insufficiency

• any other valvulopathies

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Procedure:
• intramyocardial bone marrow stem cells implantation
Patients with previous diagnosis of non-ischemic dilated cardiomyopathy. were included. Bone-marrow was collected from in the antero-superior iliac crest and mononuclear stem-cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Surgical technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5 ml), in the anterior, lateral, posterior and apical faces of the left ventricle(average 9.6 ± 2.6 x 107 cells). After the procedure, the patients were kept in the post-operative intensive care unit for a minimum period of 24 hours. They were released from the hospital in a period that varied from five to seven days.

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia do Rio Grande do Sul	Porto Alegre	RS

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety: morbidity/mortality		eighteen months	Yes